Final year medical students' understanding of issues involving generic medicines
Irrational prescribing practices are prevalent in both developed and developing countries, with extensive economic consequences (118,119). In the context of rising healthcare coast, most western countries are enhancing rational pharmacotherapy to reach best value for the continuously increasing expenditure on medicines.(123,124)prescribing lower coast generic medicines can help to achieve this objective. Education about the benefits of generic medicines should be focused at medical students, who in turn will become prescribers. To date only one study conducted in Australia to access the knowledge and perceptions of senior medical students with regard to generic medicines and generic prescribing.
Pharmacists 'perceptions of generic medicines and their role in generic medicines utilisation
Whichever policy-generic prescribing or generic substitution is adopted, the main problem is how to maintain the confidence of patient in the dispensed medications.(139)This is where the role of the pharmacist, as a professional the public recognises to be an expert on medicines, is vital.(139)In a pharmaceutical health care system in Iraq where the pharmacists have responsibility for medicine use control. The pharmacist have important role in explaining the use of generic medicines by patients.(107,140)Within this context, limited studies have been conducted to explore pharmacists' perceptions of issues surrounding generic medicines use among their patients and the impact of generic substitutions in their daily practice.
The first study on generic medicines was conducted in 1980 by Bearden et al. in Alabama, United States of America (USA). This study explored the attitudes about, perceptions of, knowledge of, and satisfaction with generic medications and made comparisons among the physicians, pharmacists, and consumers. This study explored the silent issues affecting generic medicine prescribing by physicians, dispensing by pharmacists and use by consumers. In this study, the researchers used mailed questionnaires and received responses from 412 physicians, 118 pharmacists and 105 consumers. In this study, pharmacists looked upon themselves as the most experienced health professionals in making drug product selection for consumers. In this study, physicians, pharmacist, and consumers, all these groups strongly agreed that the pharmacist should only dispense drugs produced by manufactures with large research and quality control staff. (Bearden ,1980,P. )
Sanborn and White conduct national study in 1991 and published in 1993, data were collected using a mailed questionnaire to 1000 hospital pharmacist selected randomly, 670 managed care pharmacy directors and 900consultant pharmacists. The participants in this study viewed the quality of generic medicines to be better than previous two years when the "generic scandal" hit the media in 1989.(46 azmi thesis) but this confidence in quality was not for all generic medicines. The participants in this study were asked how they were assessing the quality of generic medicine; the participants reported the using approved medicine product with therapeutic equivalence evaluation (21 azmipaper) is a useful way to evaluate the generic medicines. Most the pharmacists in this study saw the price of generic medicines which is lower than the brand medicine is a factor to stock generic medicines more.(Sanborn,1993)
A study conducted by Banahan in 1994, the researcher studied the views of community and hospital pharmacists' on generic substitutions, the data of this study were collected via mail surveys to 4059 community pharmacist's and1729 hospital pharmacists across the united state. The response rate from both groups was 20.4 for community pharmacists and 26.6 for hospital pharmacists. Outcome from this study indicate that both groups generally held positive views towards the practice of generic substitution. Similar responses (70% from community pharmacists and 69% from hospital pharmacists) comes from both groups to a question about the type of prescriptions generic medications were more suitable for 'any prescription' over the three other options of new, refill prescription only, or never. Pharmacists in these samples believed generic substitutions should not be allowed for certain drugs(narrow therapeutic index drugs).The only difference between the two groups appear in regarding substitutions for critical dose drugs had to do with liability. This divergence can probably be explained by a difference in the statements' wording. In the survey for community pharmacists, the item referred to increased personal liability, whereas the hospital pharmacists 'survey referred to the hospital's liability. Pharmacists in this study reported that 72% of patient accept generic medications when the pharmacist recommended that, so good relationship between pharmacist and patient lead to increase the use of generic medicines.(Banahan 1994)
Another study conducted in Australia by a local generic medicine manufacturer, Alphapharm, in 1995 to explore pharmacists' views on generic medicines and generic substitution. This study involves 304 metropolitan and rural pharmacists. The outcome of this study found that 80% of the pharmacies interviewed said that they depend on the doctor's brand recommendation when they dispense medicines to the patients. Regarding the quality of generic medicines, 72% of the respondent thought that generic brand either equal or exceeded the standards. In this study, some pharmacist had inaccurate perception of the quality of generic medicines. (Brand,1995).
After the France government passed the brand substitution law, Allenet and his group conducted his study in France in 2000 to evaluate the opinion and attitude of community pharmacist towards substitution. Questionnaire was used to collect data. The questionnaire was sent through a national distribution network of a pharmacy magazine. From 2000 questionnaire returned, 1000were selected randomly to be sufficient for the descriptive purposes of the study. The outcome of this study found that 90% of the participants were satisfied with the low which allowed them for generic medicine substitution, which is important to improve the image of pharmacists among healthcare system. Finally the researcher recommending that the financial incentive offered to the pharmacist is important factor to improve generic substitution practice. (Alert ,2000)
In Sweden a new pharmaceutical role was implemented in 2002 (29 review) the major element of this role was the introduction of generic substitution in pharmacy. After this role, pharmacist can substitute the cheapest medicine which contain the same active substance and consider to be therapeutically equivalent according to the list produced by the Swedish Medical Products Agency(MPA) (29 review).After the first year of the new pharmaceutical policy, a study to explore obstacles to generic substitution was conducted. The outcomes of this study appear high saving per substitution and depend on the extent to which pharmacies kept the cheapest brand in stock.(Anderson 2005)
In Australia, Hassali and his group explore the important issue affecting generic medicine dispensing and generic substitution practice among community pharmacist. In this study the author used qualitative method to collect the data, 11 community pharmacists selected conveniently using an interview guide. After thematic content analysis of the interview, the outcome of this study showed that, in general community pharmacists are comfortable in offering generic substitution to their patient and generic medicines are safe and effective in most case. But there are some circumstances regarding substituting some specific drugs. This study also showed that the community pharmacists need more education regarding the bioequivalence tests for generic medicines by medicine regulatory body. Finally the community pharmacist play important role in advising patient on generic substitution which lead to increase uptake of generic medicine.(Hassali,2007)
Pilot study from Malaysia was conducted by Hassali et al to evaluate generic practices, communication between physicians and community pharmacists, patients' acceptant of generic substitution and finally the cost savings for both pharmacy and patients. Data collected via questionnaire survey distributed to random sample of 40 community pharmacies located in the state of Penang. The outcome of this study found that the majority of generic substitution (61%) recommendation involves class B Poison, and 46% involve cardiovascular drugs. Other finding was found that the communication between physicians and pharmacist was poor. 84.4% of physicians agreed with the recommendation by pharmacist,88% of patient accept the substitution by pharmacist even this substitution include class B Poison which can be obtain via physicians prescription only, and finally the coast saving by pharmacist per month reach 70%of their coast in stock purchasing.(Hassali 2007)
Another study conducted in Malaysia in 2008 by Zaheer et al, the objective of this study was to explore the perception and practice of community pharmacists on generic medicine and generic substitution trends. A cross-sectional survey of random 40 pharmacies in four geographical regions of West Malaysia(Kuala Lumpur/Selangor, Johor Bahru, Negeri Sembilan and Penang) by using questionnaire to collect the data. The outcome of this study found that 41% of the respondent had 41-60 % of their stocks as generics. More than half of the community pharmacists said that the reason for their practice of generic substitution is the high profit margin.62% of the respondent did not agree with the concept of compulsory generic substitution. The author concludes that the branded medicines were available at community pharmacies and widely dispensed by pharmacist even for chronic disease. The practice of generic substitution and dispensing was more influenced by consumer demand than it was by pharmacist. Finally the researcher found that improving the quality of generic medicine, instituting proper generic medicine-substituting policies, and educating consumers.(Zaheer,2008)
Final year pharmacy students' understanding of issue involving generic medicines and generic substitutions
A pharmacistis the exclusive member of the healthcare team who can apply the knowledge of dosage forms in a therapeutic regimen. Since pharmacist have an important role in offering generic medicines and thus have the ability to increase the use of generic medicines among consumers, they must have an understanding of the principles and concepts of bioavailability and bioequivalence. Education about these issues should be addressed early, at the undergraduate pharmacy students. To date only one study conducted in Australia to access the knowledge and perceptions of final pharmacy students with regard to generic medicines and generic substitution.
Consumers' acceptance and understanding of generic medicines
On the whole, the patient's voice is not heard in the discussion of generic medicines. Nonetheless, the use of these medicines has become an acceptable standard among physicians all over the world (7).Problems may arise when a generic product is substituted after patient has become familiar with the branded product. Most studies which investigated attitudes, perceptions of risk and satisfaction of consumers with generic medicines were conducted in USA.
The first study in this field conducted in Florida to assess the inclination of 510 consumers to generic substitutions, the result of this study appeared that 665 of the respondents did not accept low-cost generic alternatives. Those respondents were older and had higher incomes with an impression that generic medicine with low -cost indicated less effective in treat the illness. The researcher in this study investigates the effect of 18 variables on the inclination of consumer toward generic medicines and found to only tow variables, age and effectiveness had significant effect. Older respondents were more unwilling to switch to generic medicines, which are of low-cost and less effective (Lambert ,1978).
Mason and Bearden conducted this study in Alabama to investigate salient issues affecting use of generic medicines among consumers. Respondents in this study assumed they did not face greater risks if they use generic medicines as alternative to brand one, also the respondents in this study endorsed the idea that generic medicine produces the same therapeutic effect of the brand counterpart. The respondent showed the generic medicine should produce from manufacturers with good manufacturers practice (GMP) and refuse medicines produced by unknown one. Overall, consumers had positive attitude toward generic medicine and generic substitution because lead to save their money (Mason.1980).
The study conducted in Austin and San Antonio, Texas, USA, in 1989.This study involved 621 consumers,33% of those had never purchased generic prescription medicines. The respondents in this study felt that the generic medicines were of less quality and effective and more side effects compared with their brand counterparts. Furthermore, researcher found that the respondent older than 55 years though that generic medicines were of good quality and this opinion counter younger respondents in the same study and the pervious study conducted by Lambert(Shepherd,1988).
A study involved 389 college students conducted by Tootelian et al ,1n 1989.This study focused on student perceptions of eight types of prescription medication. The respondent in this study saw that the innovative medicines were more effects and providing more value than their generic counterparts and depend on the risk of the prescription medicines, the greater risk the greater the respondent's inclination to purchase brand medicines. The respondents 'age in this study was 85% 30 years or younger(Tootelian,1988).
In Chicago, 1989, a study conducted by Podulka, the majority of 100 consumers involve in this study replied that generic medicines had same quality compared with their brand counterparts, and they agree to use generic medicines if the physicians or /and pharmacists recommended it. However, they not prefer to use this type of medicines with chronic conditions. The factors which affect in consumers' attitude toward generic medicine come into view to be their perception of their illnesses more than their perception of the generic medicines ( Podulka,1989).
A study carried by Kendall involve 295 patients who had obtained prescriptions for one of two brand-name products at one chain pharmacy in Vancouver, British Columbia, Canada. This study carried to investigate the factors that influence generic substitution, satisfaction and intention to purchase generic medicines among consumers, this study revealed that 80% of the patient agreed the offered generic substitute prescription drug. Age also played as a factor which effect on generic medicine use in addition to education and health insurance where a patient who was older, fewer educations and had health coverage was less likely to accept a substitute. The authors concluded that to increase the use of generic medicines you must have pharmacists actively promote generic medicines and patients pay the cost of the medication.( Kendall,1991).
84% of consumers were familiar with the term generic medicine. This was the outcome of the study conducted by the American Association of Retired Person (AARP) and published in 1994.33% of the respondents aged 45-65 years had asked their physician for a generic medicine and request from pharmacist to fill the prescription with generic medicine.29% of the respondents age 65years and older were likely to asked their physician to prescribe generic medicine and request from the pharmacist to fill generic medicine(AARP,1994).
In 1994, Muirhead estimated how 876 consumers across the USA viewed Managed Care and generic medicines. The result of this study found that 29% of respondents considered generic medicines and their branded counterpart had the same quality. The respondent with low-income preferred to use brand medication because they viewed, the generic medicines as being lower in quality in compression with the brand one (Muirhead,1994).
Momani et al, conducted this study in USA, explored consumer awareness of drug-management strategies(formularies, drug co-payments, prior authorization and generic substitution),303Members of Managed Care Organization in Maryland, Pennsylvania and West Virginia, USA agreed to participants in this study via mail survey.51% of the respondents showed that their health plan mandated generic substitution. The respondents showed slightly negative view towards generic substitution when they answered agreed mildly with the statements "generic substitution result in less effective medicine" and "generic substitutions compromises the quality of my medicine". Positive response was obtained from the respondents when they asked a general question regarding their attitude towards generic substitution (means ±SD=4.6 ± 1.99 on a seven-point scale).finally the researcher concluded that the consumes were most aware of generic substitution and drug co-payments as means to manage medicine costs.
Valles et al explored patients 'acceptance of the substitution of innovative medicine for generic medicine for chronic conditions in primary health care practice in Spain. 27 public primary care centers were randomized to the intervention group (8 centers) and control group (19 centers). The outcome of this study found that 98.9% of patient (4620 patient) in the intervention group who received verbal information on the benefit of the generic equivalent medicine agreed to receive a generic formulation. In the overall population, generic prescribing in the intervention group increase to 5.9% while in control group still 2.8%. This means individual educational intervention in patients with recurrence of prescription lead to an increase in generic medicine acceptable (Valles,2003).
Only one study conducted in developing countries, Brazil, by Bertoldi et al ,and published in 2005.The author estimated the percentage of generic medicine use from the total of medicines, explored theoretical and practical knowledge about generic medicine and study the common factors which affect consumers for purchasing medicines. A representative household sample was selected making a final sample of 3182 persons. Structure interview method was used to collect data. The results of this study showed that the percentage of generic medicine in total medicines was 3.9%.70% of the respondents knew that the quality of generic medicines were the same to the brand one and 86% agreed that the cost of generic medicines was less compared with brand counterpart. Only 57% of the respondents knew any packaging characteristics that distinguish generic medicines from other ones. The author concluded that the most important factors which affect choosing medicines among the patients were price and medical prescription. Patient with high income buy brand version and patient with low income buy generic version. In order to increase the use of generic medicine, the prescription must write using generic name (Bertoldi,2005)
In Australia, Hassali et al used qualitative method to explore consumers' perception and opinion of generic medicines and to investigate the barrier to their use this type of medicine. Sixteen consumers were interviewed by the researcher himself, using thematic analysis content,the researcher identified four themes regarding generic medicines use. These were: Knowledge about generic medicines, acceptance generic medicines, non-acceptance medicines, and education needs regarding safety and efficacy of generic medicines. Most patients in this study were not familiar with generic medicines' term, but they use cheap medicine term more. Cost was the major reason for patients to request generic medicines but the barriers to use this type of medicines were confusion from using different brands, side effect from using generic medicines, and reluctant of some physicians to use this type of medicines. In general, consumers had positive view toward generic medicine, and to increase the use of generic medicines in the future the researcher suggested that direct patient education by physicians and pharmacists about the safety and efficacy lead to increase the demand on the generic medicines(Hassali,2005).
Generic substitutions allowed in Norway in 2001.Pharmacists in this country are obliged to inform the patients about the availability of generic brand which is cheap compared with the innovative brand. This low gives the right to the physician and/or patient to accept or refuse the generic medicine. Kjoenniksen et al, conducted this study in Norway after three years of legislation of the low that permitted generic substitution of prescription medicines by pharmacist. Questionnaire was sent to 404 patients in Norway taking eight or more different drugs on the fifth level in the Anatomical Therapeutic Chemical (ATC) system. Response rate was 95.5%,41% of respondent didn't accepted generic substitution, two-thirds of the patient who had use generic brand were satisfied and about one-third of patients who switched had bad experience with generic medicines. Information about the generic medicines' safety and efficacy strongly affected on the decision of the patients wither use generic medicines or not especially if this information comes from physician or pharmacist (Kjoenniksen,2006).
In Filand, generic substitutions were introduced in 2003 to face the increase in medicines price. Heikkila et al conducted descriptive study to explore the opinions, attitude and experience of the physicians and customers with the used of generic medicines. Two questionnaire were used to explore customers'views, first one were handed out in 15 pharmacies in five geographical areas of Finland to customers (n=544) who had refused generic substitutions and second one were handed out in 18 pharmacies in six geographical areas to customers (n=214) who had accepted generic substitutions. The result of this study found that the cost of generic medicines which are cheap and the recommended by pharmacists to use generic medicines were the main reasons for accepting generic substitutions. Satisfaction with the medicines used before and confusion were the main reasons to refusing substitutions.( Heikkila,2007)
In Portugal, Figueiras et at conducted this study to explore the influence of the common illness influenza,asthma and angina pectoris on the level of agreement with the use of generic medicines as well as to investigate the implication of socio-demographic factors on lay beliefs about generic medicine.1278 informants was recruited from the general population of Portugal over a 4 week period. From this sample,101 not complete their questionnaires and 52 from them refuse to participants in this questionnaire, the final sample size was 1125, (61% of them was females, mean age 33 years).The response rate of this study was 88%.Participants have had positive beliefs about the efficacy of the generic medicines and there similarity with the counterpart brand. Regarding to the efficacy of the generic medicines there are significant difference according to age and level of education of the participants. The more educated and younger participants were the strongest beliefs in the efficacy of generic medicines. The participants in this study showed moderate level of agreements with the use of generic medicines for influenza, asthma, and angina pectoris. The level of agreement to use generic medicines was decrease with the acuteness of the disease. ( Figueiras,2008)
A recent study in Malaysia conducted by Al Gedadi and his group in 2008.This study investigated consumers 'perception and knowledge about the issue of generic medicine. Questionnaires forms were given to 400 respondents on the annual university open day for five days. From 396 usable forms, 28.3% of respondent were aware of the term of generic medicine.70%of respondents were unaware of the marketing of generic medicine with different names.34% of respondent get the information regarding generic medicines from the pharmacist.64% of respondent showed that the generic medicine is more cheaper than counterpart brand and 32% of the respondent perceived generic medicine to cause more side effect. The authors concluded that education by physician and pharmacist can decrease the gap in consumers knowledge and understanding about generic medicine.(Al gedadi,2008)
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